Fast Versus Slow Tenaculum Placement

Fast Versus Slow Tenaculum Placement for Office Procedures: A Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02716636

Enrollment

121

Registered

2016-03-23

Start date

2016-04-11

Completion date

2017-03-06

Last updated

2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Diseases, IUD Insertion Complication

Brief summary

The purpose of the study is to investigate whether the speed of tenaculum placement affects perceived patient pain during office transcervical procedures.

Detailed description

IUD insertion and endometrial biopsies are commonly performed in office procedures that use a tenaculum to stabilize the cervix. Patient's often complain that tenaculum placement is one of the most uncomfortable parts of these procedures. Patient's who agree to be in the study will be randomized into one of two groups, either slow tenaculum placement or fast tenaculum placement. Throughout the procedure patient's will be asked to rate the amount of pain they are experiencing using a visual analog scale. The researchers will then compare the two groups. The providers will also rate what they perceived the patient's pain to be with the procedure.

Interventions

PROCEDURESlow placement of the tenaculum

Slow placement of the tenaculum on the cervix

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years old and older * Clinic provider plans a transcervical procedure (IUD placement or endometrial biopsy) * English speaking and able to consent

Exclusion criteria

* Incarcerated * Prior LEEP (loop electrosurgical excision procedure), cryo (cryotherapy) or CKC (cold knife cone) of the cervix

Design outcomes

Primary

Measure	Time frame	Description
Pain with tenaculum placement assessed using a VAS scale	procedure	Subjects will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.

Secondary

Measure	Time frame	Description
Overall pain perception assessed using a VAS scale	procedure	Subjects will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.
Provider perception of patient pain assessed using a VAS scale	procedure	Providers will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026